Antenatal Thyrotropin-Releasing Hormone to Prevent Lung Disease in Preterm Infants
Roberta A. Ballard, M.D., Philip L. Ballard, M.D., Ph.D., Avital Cnaan, Ph.D., Jennifer Pinto-Martin, Ph.D., Deborah J. Davis, M.D., James F. Padbury, M.D., Roderic H. Phibbs, M.D., Julian T. Parer, M.D., Ph.D., Montgomery C. Hart, M.D., Frank L. Mannino, M.D., Shirley K. Sawai, M.D., for The North American Thyrotropin-Releasing Hormone Study Group
Background Pulmonary disease is common in preterm infants, despiteantenatal glucocorticoid therapy. The addition of antenatalthyrotropin-releasing hormone therapy has been reported to decreasepulmonary morbidity in these infants.
Methods We enrolled 996 women at 13 North American centers whowere in preterm labor at <30 weeks' gestation in a double-blind,placebo-controlled, randomized trial of antenatal thyrotropin-releasinghormone, given intravenously in four doses of 400 µg eachat eight-hour intervals. The primary outcome was chronic lungdisease or death of the infant on or before the 28th day afterdelivery, and secondary outcomes were respiratory distress syndromeand chronic lung disease or death at 36 weeks' postmenstrualage. Complete data were available for 981 women and their 1134live-born infants. The 769 infants born at <32 weeks' gestationwere defined as the group at risk.
Results There were no significant differences between the at-risktreatment and placebo groups in mean (±SD) birth weight(1109±354 vs. 1097±355 g), gestational age (27.9±2.1vs. 27.9±2.1 weeks), sex, or race. The frequencies ofrespiratory distress syndrome (66 percent vs. 65 percent), deathat 28 days (11 percent vs. 11 percent), chronic lung diseaseor death at 28 days (45 percent vs. 42 percent) and at 36 weeks(32 percent vs. 34 percent), and other neonatal complicationsas well as the severity of lung disease were not significantlydifferent in the at-risk treatment and placebo groups. Similarly,there were no differences in outcome between the treatment andplacebo groups for the infants born at >32 weeks' gestation.
Conclusions In preterm infants at risk for lung disease, antenataladministration of thyrotropin-releasing hormone and glucocorticoidis no more beneficial than glucocorticoid alone.
Source Information
From the Department of Pediatrics, University of Pennsylvania School of Medicine and Children's Hospital of Philadelphia (R.A.B., P.L.B., A.C.) and the University of Pennsylvania School of Nursing (J.P.-M.), Philadelphia; Children's Hospital of Eastern Ontario, Ottawa, Ont., Canada (D.J.D); Harbor–UCLA Medical Center, Torrance, Calif. (J.F.P.); University of California, San Francisco (R.H.P., J.T.P.); St. Joseph's Hospital, Phoenix, Ariz. (M.C.H.); University of California, San Diego (F.L.M.); and Good Samaritan Hospital, Phoenix, Ariz. (S.K.S.).
Address reprint requests to Dr. Roberta A. Ballard at the Division of Neonatology, Children's Hospital of Philadelphia, 34th St. and Civic Center Blvd., Philadelphia, PA 19104.
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